Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04715581

Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Old Age; Debility Digestive Cancer Digestive System Diseases Digestive System Neoplasms Frailty Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Nutrition Therapy Outcomes Pathologic Processes Pathological Conditions, Signs and Symptoms Preoperative Rehabilitation Surgery

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Huai-Jin Li, MD

CONTACT

[email protected]

About this study

Frailty is an age-related syndrome characterized with diminished physiological reserve that results in decreased homeostatic capacity and increased vulnerability to any stress from minor to major. Approximately 10% to 20% of adults aged 65 years and older present with frailty, and the incidence doubles among those of 85 years and older. Among elderly cancer patients especially those with digestive cancer, the prevalence of frailty and pre-frailty can be as high as 50%. Malnutrition often coexists with frailty, and indeed contribute to the development of frailty. As a matter of fact, the proportion of malnutrition also increases with age even in high-income countries.

Frailty is strongly associated with worsening outcomes in surgical patients, including higher delirium, high non-delirium complications, high perioperative mortality, as well as decreased activity of daily life, cognitive dysfunction and work disability in long-term survivors. Furthermore, malnutrition as a prominent factor in the development of frailty also has adverse impacts on the duration of hospitalization, complications, and survival after surgery. Therefore, it is urgently needed to understand how to enhance the recovery of these patients following surgery.

Exercises and rehabilitation, in combination with nutritional supplement, may reverse or mitigate frailty, promote postoperative recovery, and improve clinical outcomes. However, the reported effectiveness varies with interventions and are not sufficiently robust to guide good clinical practice. The purpose of this study is to investigate the effect of multimodal prehabilitation on early and long-term outcomes in elderly patients with frailty.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥65 years but <90 years;
  • Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;
  • Clinical Frailty Scale ≥5;
  • Provide written informed consent.

Exclusion criteria

  • Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
  • Inability to communicate due to coma, profound dementia, or language barrier;
  • Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
  • Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
  • Severe heart dysfunction (left ventricular ejection fraction <30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;
  • Other reasons that are considered unsuitable for study participation.

Treatment and study plan

Preoperative nutritional optimization

Dietary Supplement
  • Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7).
  • Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g/kg/d. Patients with iron deficient anemia (hemoglobin <130 g/L for men and <120 g/L for women) will be given oral iron therapy.
  • The duration of nutritional optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.

Preoperative exercise training

Behavioral
  • The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training.
  • Aerobic exercise will be performed for at least 1-2 times per day. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible.
  • Every training should be last for 45 minutes to 1 hour. If the patient can not tolerate, the training time should be reduce to 30 minutes.
  • The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.

Postoperative exercise training

Behavioral
  • Muscle strength training in the bedside and walking in the ward.
  • Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible.
  • Exercise training is performed under the supervision of physiotherpists durign hospital stay, and is reminded by regular telephone calls and phone messages after hospital discharge.

Primary outcomes

  1. A composite of delirium and non-delirium complications within 7 days after surgery (sub-study).

    Time frame: Up to 7 days after surgery.

    Delirium will be assessed with the 3-Dimensional Confusion Assessment Method. Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.

  2. Recurrence-free survival after surgery.

    Time frame: Up to two years after surgery.

    Events include recurrence, metastasis, or all-cause death, whichever come first.

Secondary outcomes

  1. Intensive care unit admission after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Intensive care unit admission after surgery.

  2. Incidence of delirium within 7 days after surgery (sub-study).

    Time frame: Up to 7 days after surgery.

    Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.

  3. Time to oral fluid intake after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Time to oral fluid intake after surgery.

  4. Time to oral food intake after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Time to oral food intake after surgery.

  5. Time to out-of-bed activity after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Time to out-of-bed activity after surgery.

  6. 6-minute walk distance at hospital discharge (sub-study).

    Time frame: At hospital discharge, up to 30 days after surgery.

    6-minute walk distance at hospital discharge.

  7. Length of hospital stay after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Length of hospital stay after surgery.

  8. Incidence of non-delirium complication within 30 days after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.

  9. All-cause 30-day mortality after surgery (sub-study).

    Time frame: Up to 30 days after surgery.

    All-cause 30-day mortality after surgery.

  10. Quality of life at 30 days after surgery (sub-study).

    Time frame: At 30 days after surgery.

    Quality of life will be assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.

  11. Cognitive function at 30 days after surgery (sub-study).

    Time frame: At 30 days after surgery.

    Cognitive function will be assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.

  12. Sleep quality at 30 days after surgery (sub-study).

    Time frame: At 30 days after surgery.

    Sleep quality will be assessed with the Pittsburgh sleep quality index which is a 9-item questionnaire that assess subjective quality of sleep during the past 1 month. The score ranges from 0 to 21, with higher score indicating poor sleep quality.

  13. Overall survival after surgery.

    Time frame: Up to 2 years after surgery.

    Events include all-cause death.

  14. Cancer specific survival after surgery.

    Time frame: Up to 2 years after surgery.

    Events are cancer-specific death which is defined as death fully attributable to the cancer for which the index surgery is performed and usually involving cancer recurrence and/or metastasis after exclusion of other causes such as stroke and myocardial infarction. Deaths from other causes are censored at the time of death.

  15. Event-free survival after surgery.

    Time frame: Up to 2 years after surgery.

    Events include recurrence/metastasis, new-onset diseases, new-onset tumors, or all-cause mortality, whichever come first.

  16. Physical activity at 30 days after surgery (sub-study).

    Time frame: At 30 days after surgery.

    Physical activity will be assessed with International Physical Activity Questionnaire-Long.

Other outcomes

  1. Intensity of pain after surgery (sub-study).

    Time frame: Up to 7 days after surgery.

    Intensity of pain will be assessed twice daily with the numeric rating scale which is a 11-point scale where 0=no pain and 10=the worst pain.

  2. Subjective sleep quality after surgery (sub-study).

    Time frame: Up to 7 days after surgery.

    Subjective sleep quality will be assessed daily with the numeric rating scale which is a 11-point scale where 0=the best sleep and 10=the worst sleep.

  3. Sleep architecture during the night of surgery (sub-study, part of enrolled patients).

    Time frame: During the night of surgery.

    Sleep will be evaluated with the polysomnographic monitoring during the night of surgery.

  4. Quality of life at 1 year after surgery.

    Time frame: At 1 year after surgery.

    Quality of life will be assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.

  5. Cognitive function at 1 year after surgery.

    Time frame: At 1 year after surgery.

    Cognitive function will be assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.

  6. Serum level of irisin before anesthesia

    Time frame: Intraoperative (Before anesthesia on the day of surgery)

    Blood samples will be collected before anesthesia. Serum will be separated and immediately frozen at -80 °C. Irisin concentration will be measured using a commercial ELISA kit, according to the manufacturer's instructions.

  7. Serum level of irisin on postoperative day 1

    Time frame: At the first day after surgery

    Blood samples will be collected before anesthesia. Serum will be separated and immediately frozen at -80 °C. Irisin concentration will be measured using a commercial ELISA kit, according to the manufacturer's instructions.

  8. Physical activity at 3 months, 6 months and 1 year after surgery.

    Time frame: At 3 months, 6 months and 1 year after surgery

    Physical activity will be assessed with International Physical Activity Questionnaire-Long.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD

CONTACT

[email protected]

+8613910731903

Huai-Jin Li, MD

CONTACT

[email protected]

+8613488659162

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Jan 20, 2021
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.